Genotoxicity Mechanisms
Found 4 free book(s)
ICH M7 – Regulatory Updates & Industry Practices
www.lhasalimited.org• Genotoxicity – Damage to genetic material (DNA and chromosomes ). • Genotoxicants that are non-mutagenic typically have threshold mechanisms and usually do not pose carcinogenic risk in humans at the level ordinarily present as impurities. • There is growing evidence of thresholds in mutagenicity (MMS, EMS etc.).
E 2 E Pharmacovigilance Planning (Pvp)
www.ema.europa.eunephrotoxicity, hepatotoxicity, genotoxicity, carcinogenicity etc.) • General pharmacology (cardiovascular, including QT interval prolongation; nervous system; etc.) • Drug interactions • Other toxicity-related information or data. If the product is intended for use in special populations, consideration should be given to
Sodium laurilsulfate used as an excipient
www.ema.europa.euskin barrier by several mechanisms have been described including a direct action on corneocytes leading to their swelling in size, denaturation of keratin structures via direct binding, elevation of stratum corneum pH and alteration of lipid synthesis in this layer, possibly as a result of local pH changes.
Toxicological Profile for Perfluoroalkyls
www.atsdr.cdc.govPERFLUOROALKYLS ii . DISCLAIMER . Use of trade names is for identification only and does not imply endorsement by the Agency for Toxic Substances and Disease Registry, the Public Health Service, or the U.S. Department of Health and Human